A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE)
NCT ID: NCT01484496
Last Updated: 2018-06-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
839 participants
INTERVENTIONAL
2011-11-16
2015-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo plus standard therapy
Placebo SC plus standard therapy; placebo administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with final evaluation at Week 52 in the double-blind period. In the open-label extension period, placebo subjects who opt to participate will receive belimumab 200 mg SC weekly for an additional 6-months.
Placebo
Placebo
Standard therapy
Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.
Belimumab 200 mg SC plus standard therapy
Belimumab 200 mg SC plus standard therapy; belimumab administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with a final evaluation at Week 52 in the double-blind period. In the open-label extension period, subjects who opt to participate will continue on the same dose of belimumab for an additional 6-months.
Belimumab 200 mg SC
Belimumab 200 mg SC
Standard therapy
Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.
Interventions
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Placebo
Placebo
Belimumab 200 mg SC
Belimumab 200 mg SC
Standard therapy
Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.
3. Active SLE disease.
4. Autoantibody-positive.
5. On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate, etc.)
Exclusion Criteria
2. Have received treatment with any B cell targeted therapy (for example, rituximab or belimumab).
3. Have received treatment an investigational biological agent in the past year.
4. Have received intravenous (IV) cyclophosphamide within 90 days of Day 0.
5. Have severe active lupus kidney disease.
6. Have severe active central nervous system (CNS) lupus.
7. Have required management of acute or chronic infections within the past 60 days.
8. Have current drug or alcohol abuse or dependence.
9. Have a positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
10. Have a history of hypersensitivity reactions to contrast agents or biological medicines.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Human Genome Sciences Inc., a GSK Company
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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Birmingham, Alabama, United States
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Peoria, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Jonesboro, Arkansas, United States
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La Jolla, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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San Jose, California, United States
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San Leandro, California, United States
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Tustin, California, United States
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Upland, California, United States
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Bridgeport, Connecticut, United States
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Aventura, Florida, United States
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Boca Raton, Florida, United States
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Boca Raton, Florida, United States
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Coral Gables, Florida, United States
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Fort Lauderdale, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Orlando, Florida, United States
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Plantation, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Duluth, Georgia, United States
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Lawrenceville, Georgia, United States
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Marietta, Georgia, United States
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Boise, Idaho, United States
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Springfield, Illinois, United States
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Baton Rouge, Louisiana, United States
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New Orleans, Louisiana, United States
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Baltimore, Maryland, United States
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Cumberland, Maryland, United States
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Hagerstown, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Saint Clair Shores, Michigan, United States
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Jackson, Mississippi, United States
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St Louis, Missouri, United States
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Las Cruces, New Mexico, United States
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Brooklyn, New York, United States
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Lake Success, New York, United States
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Manhasset, New York, United States
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New York, New York, United States
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Smithtown, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Greenville, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Bethlehem, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Charleston, South Carolina, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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Orangeburg, South Carolina, United States
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Jackson, Tennessee, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Nassau Bay, Texas, United States
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Royalty, Texas, United States
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Arlington, Virginia, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Pennsylvania, Wyoming, United States
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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La Plata, Buenos Aires, Argentina
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Ciudad Autonoma Buenos Aires, , Argentina
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Ciudad Autonoma Buenos Aires, , Argentina
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Vienna, , Austria
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Brussels, , Belgium
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Brussels, , Belgium
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Liège, , Belgium
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Cuiabá, Mato Grosso, Brazil
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Juiz de Fora, Minas Gerais, Brazil
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Curitiba, Paraná, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Rio de Janeiro, , Brazil
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Salvador, , Brazil
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São Paulo, , Brazil
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Santiago, Región Metro de Santiago, Chile
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Santiago, , Chile
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Viña del Mar, , Chile
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Bucaramanga, , Colombia
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Medellín, , Colombia
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Osijek, , Croatia
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Rijeka, , Croatia
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Zagreb, , Croatia
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Prague, , Czechia
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Zlín, , Czechia
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Copenhagen, , Denmark
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Odense C, , Denmark
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Paris, , France
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Paris, , France
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Pessac, , France
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Strasbourg, , France
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Suresnes, , France
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Vandœuvre-lès-Nancy, , France
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Würzburg, Bavaria, Germany
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Bad Nauheim, Hesse, Germany
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Hanover, Lower Saxony, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Mainz, Rhineland-Palatinate, Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Debrecen, , Hungary
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Zalaegerszeg, , Hungary
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Pisa, Tuscany, Italy
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Padua, Veneto, Italy
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Genova, , Italy
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Fukuoka, , Japan
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Fukuoka, , Japan
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Hokkaido, , Japan
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Miyagi, , Japan
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Nagasaki, , Japan
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Okinawa, , Japan
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Shizuoka, , Japan
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Kuala Lumpur, , Malaysia
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Seremban, Negeri Sembilan, , Malaysia
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Guadalajara, Jalisco, Mexico
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Guadalajara, Jalisco, Mexico
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Cuernavaca, Morelos, Mexico
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Mérida, Yucatán, Mexico
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México, , Mexico
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México, , Mexico
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San Luis Potosí City, , Mexico
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Cebu City, , Philippines
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Davao City, , Philippines
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Iloilo City, , Philippines
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Las Piñas, , Philippines
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Manila, , Philippines
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Manila, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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Bydgoszcz, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Wroclaw, , Poland
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Almada, , Portugal
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Amadora, , Portugal
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Coimbra, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Moscow, , Russia
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Saint Petersburg, , Russia
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Yaroslavl, , Russia
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Belgrade, , Serbia
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Belgrade, , Serbia
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Singapore, , Singapore
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Barcelona, , Spain
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Barcelona, , Spain
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Granada, , Spain
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Gothenburg, , Sweden
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Lund, , Sweden
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Stockholm, , Sweden
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Gueishan Township,Taoyuan County, , Taiwan
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Rajathevee, , Thailand
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Ratchatewi, , Thailand
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Songkhla, , Thailand
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Odesa, , Ukraine
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Poltava, , Ukraine
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Vinnytsia, , Ukraine
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Zaporizhzhia, , Ukraine
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Coventry, Warwickshire, United Kingdom
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Birmingham, , United Kingdom
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London, , United Kingdom
Countries
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References
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Nikolopoulos D, Cetrez N, Lindblom J, Parodis I. Neuropsychiatric involvement in systemic lupus erythematosus contributes to organ damage beyond the nervous system: a post-hoc analysis of 5 phase III randomized clinical trials. Rheumatol Int. 2024 Sep;44(9):1679-1689. doi: 10.1007/s00296-024-05667-5. Epub 2024 Aug 8.
Jagerback S, Gomez A, Parodis I. Predictors of renal flares in systemic lupus erythematosus: a post-hoc analysis of four phase III clinical trials of belimumab. Rheumatology (Oxford). 2025 Feb 1;64(2):623-631. doi: 10.1093/rheumatology/keae023.
Gomez A, Jagerback S, Sjowall C, Parodis I. Belimumab and antimalarials combined against renal flares in patients treated for extra-renal systemic lupus erythematosus: results from 4 phase III clinical trials. Rheumatology (Oxford). 2024 Feb 1;63(2):338-348. doi: 10.1093/rheumatology/kead253.
Brunner HI, Abud-Mendoza C, Mori M, Pilkington CA, Syed R, Takei S, Viola DO, Furie RA, Navarra S, Zhang F, Bass DL, Eriksson G, Hammer AE, Ji BN, Okily M, Roth DA, Quasny H, Ruperto N. Efficacy and safety of belimumab in paediatric and adult patients with systemic lupus erythematosus: an across-study comparison. RMD Open. 2021 Sep;7(3):e001747. doi: 10.1136/rmdopen-2021-001747.
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Maslen T, Bruce IN, D'Cruz D, Ianosev M, Bass DL, Wilkinson C, Roth DA. Efficacy of belimumab in two serologically distinct high disease activity subgroups of patients with systemic lupus erythematosus: post-hoc analysis of data from the phase III programme. Lupus Sci Med. 2021 Feb;8(1):e000459. doi: 10.1136/lupus-2020-000459.
Lokhandwala T, Yue B, Coutinho AD, Bell CF. Within-trial economic analysis of flare data from the BLISS-SC trial of subcutaneous belimumab in systemic lupus erythematosus. Lupus Sci Med. 2021 Feb;8(1):e000438. doi: 10.1136/lupus-2020-000438.
Doria A, Bass D, Schwarting A, Hammer A, Gordon D, Scheinberg M, Fox NL, Groark J, Stohl W, Kleoudis C, Roth D. A 6-month open-label extension study of the safety and efficacy of subcutaneous belimumab in patients with systemic lupus erythematosus. Lupus. 2018 Aug;27(9):1489-1498. doi: 10.1177/0961203318777634. Epub 2018 May 28.
Doria A, Stohl W, Schwarting A, Okada M, Scheinberg M, van Vollenhoven R, Hammer AE, Groark J, Bass D, Fox NL, Roth D, Gordon D. Efficacy and Safety of Subcutaneous Belimumab in Anti-Double-Stranded DNA-Positive, Hypocomplementemic Patients With Systemic Lupus Erythematosus. Arthritis Rheumatol. 2018 Aug;70(8):1256-1264. doi: 10.1002/art.40511. Epub 2018 Jun 15.
Stohl W, Schwarting A, Okada M, Scheinberg M, Doria A, Hammer AE, Kleoudis C, Groark J, Bass D, Fox NL, Roth D, Gordon D. Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus: A Fifty-Two-Week Randomized, Double-Blind, Placebo-Controlled Study. Arthritis Rheumatol. 2017 May;69(5):1016-1027. doi: 10.1002/art.40049. Epub 2017 Apr 7.
Study Documents
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Document Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
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Other Identifiers
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2011-003814-18
Identifier Type: -
Identifier Source: secondary_id
HGS1006-C1115
Identifier Type: -
Identifier Source: secondary_id
112341
Identifier Type: -
Identifier Source: org_study_id
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